Executive Director, Quality Enablement CPS

Dallas, IA - USA

Monthly Salary: Not Disclosed

Posted on: 7 days ago

Vacancies: 1 Vacancy

Job Summary

The CPS organization is seeking a Senior Director or Executive Director Quality Enablement to provide enterprise-level leadership in defining governing and advancing quality oversight across early-phase and pharmacology studies. This role is critical to shaping CPS quality strategy and positioning quality as a strategic differentiator for sponsors.

Job Overview

This executive leader partners closely with CPS Executive Leadership and key cross-functional stakeholdersincluding Clinic Operations Project Management Data & Analytics Quality and Technologyto embed Quality by Design (QbD) and proactive risk-based quality management into CPS study delivery models.

The Senior/Executive Director is accountable for ensuring that CPS operational processes standards and training programs are fit-for-purpose scalable and inspection-ready while fully aligned with global regulatory expectations. This role drives a forward-looking quality enablement framework that supports innovation accelerates early-phase development and strengthens sponsor confidence.

As a strategic advisor to senior leadership this individual influences enterprise decision-making leads change at scale and ensures consistent high-quality execution across CPS environments.

Summary of Responsibilities:

CPS Quality Enablement Strategy & Governance

Define and own the CPSspecific quality enablement strategy ensuring alignment with Fortrea enterprise quality standards and regulatory guidance (FDA EMA ICH E6/E8 R1).
Establish quality enablement governance models standards and operating procedures tailored to CPS study designs clinicbased execution and earlyphase risk profiles.
Serve as the senior escalation point for CPS portfoliolevel quality risks protocol complexity data integrity concerns and inspection readiness issues.

Portfolio Oversight & Quality Assurance

Provide oversight of quality enablement execution across the CPS clinical trial portfolio including firstinhuman SAD/MAD bioavailability bioequivalence and other clinical pharmacology studies.
Ensure consistent development approval and oversight of Integrated Quality Risk Management Plans (IQRMPs) strategies.
Review CPSlevel risk trends KRIs and performance indicators to drive proactive mitigation and continuous quality improvement.

Leadership & People Development

Lead coach and develop quality enablement leaders and teams embedded within CPS building sustainable capability across clinics and delivery teams.
Partner with CPS leadership on workforce planning capability development and succession planning related to quality and quality enablement roles.
Foster a culture of proactive risk ownership accountability and continuous improvement across CPS.

CrossFunctional & Executive Partnership

Act as a trusted advisor to CPS senior and executive leadership on quality enablement strategy quality risk posture and inspection readiness.
Collaborate with Clinic Operations Project Management Data Management Biostatistics Safety and Quality to embed quality enablement into CPS delivery models.
Represent CPS in internal audits sponsor audits regulatory inspections and governance forums.

Client Engagement & Business Development

Serve as a senior CPS quality enablement representative in RFPs RFIs bid defenses and sponsor governance meetings.
Articulate Fortreas CPSspecific quality enablement value proposition demonstrating differentiation in earlyphase quality oversight and execution.
Support complex sponsor discussions related to risk management protocol complexity data integrity and inspection readiness.

Operational Excellence & Change Leadership

Lead continuous improvement of CPS processes tools templates and training materials.
Sponsor and lead change management initiatives to mature quality enablement adoption across CPS clinics and project teams.
Ensure CPS quality enablement knowledge management lessons learned and best practices are consistently captured and shared.

Qualifications (Minimum Required):

Bachelors degree required; advanced degree preferred.
Fortrea may consider relevant and equivalent experience and successful project outcomes in lieu of educational requirements.

Experience/Skills (Minimum Required):

10 years of experience in clinical research quality or related fields (CRO pharma biotech).
5 years of progressive leadership experience in quality management or process improvements preferably within earlyphase or clinical pharmacology environments.
Demonstrated experience leading global crossfunctional CPS teams and influencing senior stakeholders.
Extensive sponsorfacing experience including executivelevel interactions.

Strong understanding of CPS study designs clinic operations and earlyphase regulatory expectations.
Proven experience with audits inspections CAPA and quality governance.

Deep expertise in quality enablement and CPS study execution
Strong executive presence with the ability to influence without authority
Advanced data analytics and risk signal interpretation capability
Strategic leadership combined with strong operational execution
Excellent communication presentation and stakeholder management skills
Change leadership and organizational transformation capability
Strong business and financial acumen within a CRO/CPS environment

Physical Demands / Work Environment:

Work Environment:

Work is performed in an office environment with exposure to electrical office equipment.
Occasional drives to site locations with occasional travel both domestic and international.

Physical Requirements:

Frequently stationary for 6-8 hours per day.
Repetitive hand movement of both hands with the ability to make fast simple repeated movements of the fingers hands and wrists.
Occasional crouching stooping with frequent bending and twisting of upper body and neck.
Ability to access and use a variety of computer software developed both in-house and off-the-shelf.
Light to moderate lifting and carrying or moving of objects including luggage and laptop computer with a maximum lift of 15-20 lbs.
Regular and consistent attendance.
Varied hours may be required.

Learn more about our EEO & Accommodations request here.

Required Experience:

Director